• Two new partnerships enhance QIAGEN’s capabilities to support pharma partner clinical trials with significant expansion of MRD capabilities – especially using QIAcuity digital PCR
• Tracer Biotechnologies partnership to develop blood-based minimal residual disease (MRD) tests on QIAcuity digital PCR systems for solid cancer tumors
• Collaboration with Foresight Diagnostics aims to develop a kit version of its CLARITY™ NGS assay for use in lymphoma

VENLO, Netherlands–(BUSINESS WIRE)– QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics. The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.

Minimal residual disease (MRD) testing is becoming a cornerstone of oncology by enabling early detection of cancer recurrence and guiding timely adjustments to therapy from a blood sample. These new partnerships support the growing demand for decentralized, non-invasive tools that advance precision medicine and help deliver more personalized care.

“These new partnerships represent an important step in strengthening QIAGEN’s leadership in oncology by aiming to bring innovative MRD technologies into clinical practice,” said Jonathan Arnold, Vice President, Head of Precision Partnering Diagnostics at QIAGEN. “We want to in particular strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable laboratories and healthcare providers worldwide to use MRD insights for guiding personalized treatment decisions for cancer patients.”

Under the new collaborations:

• Tracer Biotechnologies, a developer of blood-based molecular diagnostics for cancer, is working with QIAGEN to create companion diagnostics for MRD testing in solid tumors. These assays, designed for use on QIAGEN’s QIAcuity digital PCR platform, are designed to enable the use of minimally invasive blood samples to monitor residual disease with high sensitivity. The approach offers a cost-efficient and quick way to support decentralized implementation in clinical laboratories with results comparable to those generated using next-generation sequencing technologies.

“Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity,” said Mark Kaganovich, CEO, Tracer Biotechnologies. “With QIAcuity’s sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients.”

• Foresight Diagnostics and QIAGEN are creating a kit-based version of the Foresight CLARITY™ assay, a circulating tumor DNA (ctDNA)-based NGS test for certain types of lymphoma. Transitioning the assay from a CLIA central laboratory service to an in-lab kit is designed to allow for broader clinical access and supports pharmaceutical-sponsored trials with companion diagnostic applications.

“We are excited to partner with QIAGEN to accelerate the development of a kit-based version of our CLARITY™ assay and expand our ability to support pharmaceutical companies in developing companion diagnostics and IVD solutions globally,” said Jake Chabon, CEO of Foresight Diagnostics. “By combining our leading MRD technology with QIAGEN’s global infrastructure and expertise, we are well-positioned to deliver a diagnostic kit that has the potential to enable personalized treatment strategies for lymphoma patients worldwide.”

MRD testing offers a highly sensitive way to monitor treatment response, identify patients at risk of relapse before symptoms appear and inform decisions on therapy usage. It is also emerging as a surrogate endpoint in clinical trials, accelerating drug development and regulatory review.

QIAGEN’s MRD portfolio spans sample technologies and testing platforms that support workflows from sample to insight. This includes the QIAsymphony system for automated sample preparation, with the new generation QIAsymphony Connect upgraded version being prepared for launch in late 2025, along with PAXgene blood collection tubes for stabilized blood draws. QIAGEN also offers an extensive range of kits for use on the QIAcuity family of digital PCR instruments as well as the QIAseq targeted gene panels for use on third-party NGS systems. Complementing these solutions is the portfolio of QIAGEN Digital Insights solutions that offer integrated bioinformatics for comprehensive NGS data analysis and interpretation to enable comprehensive MRD results.

For more information about QIAGEN’s MRD solutions,visit https://www.qiagen.com/us/applications/digital-pcr-mdx.